Recent Publications - Compliance, Investigations & White Collar
February 17, 2022 |
Nearly 8 years ago, I published an article reviewing FDA’s failure to enforce the Dietary Supplement Health and Education Act of 1994 (DSHEA), especially in connection with the requirement that new dietary ingredients (NDIs) provide evidence of a reasonable expectation of safety.
I expressed concerns about the potential public health risk posed by knockoffs of NDIs ofRead More
January 3, 2022 | |
The New York State Office of Cannabis Management (OCM) has announced regulations concerning the manufacturing and labeling of cannabinoid hemp products, and the availability of an online portal to facilitate required state licensure. Cannabinoid hemp products sold in the state must comply with the regulations by April 25, 2022. The OCM will be reaching outRead More
December 3, 2021 |
Steven Shapiro authored the article, “Should the Dietary Supplement Industry Support FDA’s Push for Mandatory Product Listing?” for Nutrition Industry Executive.
The article discusses talk of creating “DSHEA 2.0” which would a require a “mandatory product listing” of all dietary supplement products to be submitted to the FDA. There seems to be a split inRead More
June 1, 2021 | |
On May 13, 2021, Rivkin Radler Partner, and former OMIG First Deputy, Robert Hussar kicked off Rivkin Radler’s new Healthcare Compliance Lunch and Learn Series. He interviewed Frank T. Walsh, Jr., who offered his first public comments since assuming his role as Acting NYS Medicaid Inspector General (pending State Senate confirmation).
Mr. Walsh provided healthRead More
March 24, 2021 | |
This week, the U.S. Food and Drug Administration (FDA) issued Warning Letters that effectively declare that the presence of cannabidiol (CBD) as an inactive ingredient in topical over-the-counter (OTC) drug products is a violation of the federal Food, Drug, and Cosmetic Act (FD&C Act).
In a news release issued on March 22, 2021 the FDARead More
March 11, 2021 | |
Near the end of 2020, in mid-December, the Federal Trade Commission (FTC) launched what it referred to as “Operation CBDeceit,” a law enforcement sweep challenging allegedly unproven representations that CBD products could treat diseases and serious medical conditions such as cancer, diabetes, Alzheimer’s disease and more.
At the same time, the FTC announced proposed settlementsRead More
February 1, 2021 | |
As a candidate running for the office he now holds, President Biden advocated decriminalizing the use of marijuana, automatically expunging all prior marijuana use convictions, legalizing marijuana for medical purposes and rescheduling marijuana from Schedule I to Schedule II in order to permit scientific research into its effects, while leaving decisions regarding legalization of marijuana forRead More
September 17, 2020 |
Bob Kern and Marc Ullman published the article, “Cannabis Investments and Exit Strategies: A Case Study” in Pratt’s Journal of Bankruptcy Law.
The article discusses the easiness with which investors can make investments in cannabis companies. However, due to the risks, they would be well-advised to have an exit plan in the event their investmentRead More
August 3, 2020 | | |
It is relatively easy for investors to make investments in cannabis companies. Given the risks, however, they would be well-advised to have an exit plan in the event their investment does not live up to their expectations.
An investor decided to make an investment in a Colorado company that was seeking to createRead More
July 30, 2020 |
Brian Bank published the article, “Cross-Border E-discovery in the Privacy Era,” in the Summer 2020 issue of USLAW Magazine.
Click here to read the article.Read More
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